Clearance Summary
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A received FDA 510(k) clearance under submission number K093858, sponsored by St. Jude Medical, Cardiac Rhythm Management Divisi. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-04-02.
- Submission: K093858
- Applicant / Sponsor: St. Jude Medical, Cardiac Rhythm Management Divisi
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2010-04-02
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.